Clinical Trial for the treatment of acute myeloid leukaemia in children and adolescents
- Conditions
- Acute myeloblastic leukaemia [AML]C92.0
- Registration Number
- DRKS00022788
- Lead Sponsor
- GPOH gemeinnützige GmbH AML-BFM Studienzentrale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 164
Diagnosis of an AML (It. WHO classification 2008)
Acute leukemia of ambiguous lineage (MPAL; It. WHO classifiction 2008: acute undifferenziated leukemia (AUL, bilineal leukemia; biphenotype leukemias, dominant myelogenous; lineage switch)
Ages 0 to 18 years
Informed consent for study participation and data handling
Existing syndromes which exlude treatment
Patients with trisomy 21 and ML-DS and/or transient myeloproliferativem syndrome (link to the TMD-prevention study or the ML-DS 2006 study)
Patients with an acute promyeloblastic leukemia (APL), AML with t(15;17)
Treatment related AML
Refusal of treatment/ missing informed consent to treatment or protocol
Participation in another clinical trial with an intervention interfering with the aims of this trial
Pregnancy
breast feeding
Known allergic reaction to the study drug
Patients of child-bearing age who decline a pregnancy test or refuse appropriate prevention of pregnancy.
Previous-therapy with cytostatistic medicines of more than 14 days.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the event-free survival of children and adolescents with AML through the introduction of Clofarabine in induction therapy.
- Secondary Outcome Measures
Name Time Method Minimization of treatment toxicity and improvement in quality of life by shortening the maintenance therapy without worsening the prognosis.